PRECAUTIONS

1. Metallic implants can loosen, bend, fracture, corrode, migrate, cause pain, or stress shield bone, even after a fracture has healed. If a device remains implanted after complete healing, it can actually increase the risk of refracture in an active individual. Therefore, these devices are temporary and should be removed after completing their intended function – i.e., aiding in the bone healing process. Once this temporary implant has completed its intended function as an aid to fusion, the Facet-Link Stabilization Platform should be removed. Implant removal should be followed by adequate postoperative management to avoid refracture. If the patient is older, and has a low activity level, the surgeon may elect not to remove the implant, thus eliminating the risks associated with a second surgery. Specific patient’s anatomy may present various facet diameters throughout the length of the spine. Therefore, care should be taken by the physician to ensure that the appropriate diameter and length of facet screw is selected based on the specific patient’s anatomy. All device versions require care with respect to preservation of bone stock which is necessary to achieve solid fixation, including the facet joints and pars interarticularis. Care should be taken to assure that the decompression will not exceed the maximum span of the device to be implanted: 8 mm for the HEMI device and 26 mm for the MINI as measured using the resection guide provided with the instrument set.
Before using the Facet-Link Stabilization Platform, the physician should carefully consider the levels of implantation, patient weight, patient activity level, any other patient conditions that may impact on the performance of the system.

PREOPERATIVE WARNINGS
1. Only patients that meet the criteria described in the indications should be selected.
2. Patient condition and/or predispositions, such as those addressed in the aforementioned contraindications, should be avoided.
3. Care should be used in the handling and storage of the implants. The implants should not be scratched or damaged. Implants and instruments should be protected during storage and from corrosive environments.
4. All non-sterile parts should be cleaned and sterilized before use.
5. Devices should be inspected for damage prior to implantation.
6. Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.

INTRAOPERATIVE WARNINGS
1. Instructions for Use should be carefully followed.
2. Extreme caution should be exercised at all times around the spinal cord and nerve roots. This is especially true when inserting the screws. Damage to spinal nerves may cause loss of neurological function.
3. The screws and washers should not be scratched or notched, since such actions may reduce the functional strength of the construct.
4. Place the screws as far away as possible from the spinal cord and nerve roots. Damage to spinal nerves may cause loss of neurological function.
5. The Jamshidi should be placed on the starting point under direct visualization. Fluoroscopy can be used as additional confirmation of the correct placement and direction.
6. For the Translaminar trajectory, care should be taken to ensure the starting point is at the superior third of the spinous process where it joins the lamina.
7. The gauge measures the length of the K-wire which is within the bone. Care should be taken to ensure the distal tip of the K-wire is positioned at the desired screw depth when the measurement is taken.
8. Care should be taken to ream only until the cortex of the superior articular process has been perforated. Reaming beyond this point may inadvertently drive the K-wire past the lateral cortex of the vertebral body and into the soft tissues, or will cause the K-wire to be pulled out as the drill is removed. A needle holder can be used to manage K-wire depth by grasping it where it extends from the back of the drill.
9. Maintain control of the washer with the washer holder as the screw is being delivered, and release it as the screw begins to secure to the bone.
10. Caution should be taken during the K-Wire insertion to avoid bending of the wire.
11. Caution should be taken during reaming in order to maintain the reamer and the recommended power tool aligned.
12. Minor perforation of the dorsal cortex of the lamina can occur without significant complication.
13. The placement of the screws should be verified radiographically.
14. Before closing the soft tissues, all the screws should be fully seated within the device, and tightened to their instrument limited torque.
15. For the MINI device, the set screws at each end of the adjustable monorail must be tightened to their instrument limited torque. Caution: The application of excessive torque may cause the thread to strip, reducing fixation or causing loosening.
16. The torque limiter is designed for clockwise operation. Always use it as intended. An audible click indicates the torque limit. Counterclockwise operation is not intended and will result in non- specified torque values above the nominal torque.

POSTOPERATIVE WARNINGS
1. During the postoperative phase, it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.
2. Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as other complications. To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques.
3. Detailed instructions on the use and limitation of the device should be given to the patient. If partial weight bearing is recommended or required before firm bony union is achieved, the patient must be warned that bending, loosening and/or breakage of the device(s) may occur as a result of early weight-bearing or muscular activity. The risk of bending, loosening or breakage of a temporary
internal fixation device during postoperative rehabilitation may be increased if the patient is active, or if the patient is debilitated, demented, or otherwise unable to use crutches or other weight supporting devices. The patient should be warned to avoid falls, sudden jolts to the spine, or sudden severe changes in spinal position.
4. To allow maximum opportunity for a successful surgical outcome, the patient or device should not be exposed to mechanical vibrations that may loosen the device. The patient should be warned of this possibility, and instructed to restrict physical activities, especially lifting and twisting motions, and any sort of sports participation. The patient should be advised not to smoke, or consume alcohol, non-steroidals, or aspirin, during the healing process.
5. If a non-union develops, or if the device(s) loosens, bends, and/or breaks, the device should be removed immediately before serious injury occurs. Failure to immobilize a delayed or non-union of bone will result in excessive and repeated stresses on the implants. By the mechanism of fatigue, these stresses can cause eventual bending, loosening or breakage of the device(s). The patient must be adequately warned of these hazards and closely supervised to ensure cooperation until bony union is achieved.
6. The Facet-Link Stabilization Platform is a temporary internal fixation device. Internal fixation devices are designed to stabilize the operative site during the normal healing process. After healing, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. If the device is not removed following completion of its intended use, any of the following complications may occur:
(a) Corrosion, with localized tissue reaction or pain,
(b) Migration of implant position resulting in injury,
(c) Risk of additional injury from postoperative trauma,
(d) Bending, loosening, and/or breakage, which could make removal impractical or difficult,
(e) Pain, discomfort, or abnormal sensations due to the presence of the device,
(f) Bone loss caused by stress shielding.
7. Implant removal should be followed by adequate postoperative management to avoid fracture.
8. Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible. As with all orthopedic implants, the screws should never be reused under any circumstances.